A Trial of GC4419 in Patients With Critical Illness Due to COVID-19

March 14, 2022 updated by: Galera Therapeutics, Inc.

A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)

A Trial of GC4419 in Patients with Critical Illness due to COVID-19

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Research
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects at least 18 years of age.
  2. Ability to understand and the willingness to sign a written informed consent.
  3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization
  4. Requirement for intensive inpatient hospital care
  5. Acute hypoxemic respiratory failure typifying ARDS
  6. Adequate liver function
  7. Use of effective contraception

Exclusion Criteria:

  1. Expected survival for less than 48 hours after randomization
  2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis
  3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis
  4. Requirement for extra-corporeal membrane oxygenation (ECMO)
  5. Acute Myocardial Infarction (AMI)
  6. Active bleeding requiring transfusion
  7. Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2
  8. Female patients who are pregnant or breastfeeding
  9. Requirement for concurrent treatment with nitrates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active GC4419
Arm A
Drug: GC4419
180 Minute IV Infusion
Other Names:
  • Avasopasem
PLACEBO_COMPARATOR: Placebo
Arm B
Drug: Placebo
180 Minute IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 Day All-cause Mortality
Time Frame: 28 days
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galera Therapeutics, Inc.

Investigators

  • Study Chair: Jon Holmlund, MD, Study Chair

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2020

Primary Completion (ACTUAL)

May 28, 2021

Study Completion (ACTUAL)

May 28, 2021

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (ACTUAL)

September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COV-4419-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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